Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial of MST-188 (purified poloxamer 188) Injection in Subjects with Sickle Cell Disease Experiencing Vaso-Occlusive Crisis - Evaluation of Purified Poloxamer 188 in Subjects in Crisis (EPIC)

Mast Therapeutics, Inc.0 个研究点目标入组 388 人开始时间: 2014年4月9日最近更新: 2016年10月17日

适应症

试验速览

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•1. Age 4 through 65 years
•2. Subject has a confirmed diagnosis of HbSS, HbSC, HbSß+thal, or HbSß0thal
•3. Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral analgesia
•4. Subject requires hospitalization
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 232
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 155
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•1. Subject has acute chest syndrome
•2. Subject's laboratory results indicate inadequate organ function
•3. Subject is pregnant or nursing an infant
•4. Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 months
•5. Subject has been transfused within the past 14 days
•6. Subject is hospitalized for a condition other than VOC
•7. Subject has complications related to SCD

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